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PHR1343

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Sulfadiazine

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Sulfadiazine, 4-Amino-N-(2-pyrimidinyl)benzenesulfonamide, N1-(Pyrimidin-2-yl)sulfanilamide
Empirical Formula (Hill Notation):
C10H10N4O2S
CAS Number:
68-35-9
Molecular Weight:
250.28
Beilstein:
6733588
EC Number:
200-685-8
MDL number:
MFCD00006065
UNSPSC Code:
41116107
PubChem Substance ID:
329823328
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to Ph. Eur. S1800000
traceable to USP 1625009

API family

sulfadiazine

CofA

current certificate can be downloaded

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

mp

253 °C (dec.) (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-30°C

SMILES string

Nc1ccc(cc1)S(=O)(=O)Nc2ncccn2

InChI

1S/C10H10N4O2S/c11-8-2-4-9(5-3-8)17(15,16)14-10-12-6-1-7-13-10/h1-7H,11H2,(H,12,13,14)

InChI key

SEEPANYCNGTZFQ-UHFFFAOYSA-N

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General description

Sulfadiazine is a bacteriostatic drug, that belongs to the class of medication referred as sulfonamide antibiotics. It is generally used in the treatment of cerebral meningitis, pneumonia, staphylococcal and streptococcal sepsis.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Sulfadiazine may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC3953 in the slot below. This is an example certificate only and may not be the lot that you receive.

related product

Product No.
Description
Pricing

1625009

Sulfadiazine, United States Pharmacopeia (USP) Reference Standard

1633506

Sulfanilic acid, United States Pharmacopeia (USP) Reference Standard

1612608

Silver sulfadiazine, United States Pharmacopeia (USP) Reference Standard

S1800000

Sulfadiazine, European Pharmacopoeia (EP) Reference Standard

Y0001469

Sulfadiazine impurity A, European Pharmacopoeia (EP) Reference Standard

Y0001480

Sulfadiazine for identification of impurity F, European Pharmacopoeia (EP) Reference Standard

Y0001462

Acetylsulfadiazine, European Pharmacopoeia (EP) Reference Standard

PHR1419

Sulfanilic Acid, Pharmaceutical Secondary Standard; Certified Reference Material

BP312

Sulfadiazine, British Pharmacopoeia (BP) Reference Standard

PHR2654

Silver Sulfadiazine, Pharmaceutical Secondary Standard; Certified Reference Material

Signal Word

Warning

Hazard Statements

H302,H361d,H411

Hazard Classifications

Acute Tox. 4 Oral - Aquatic Chronic 2 - Repr. 2

WGK

WGK 2

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Determination of the content and the related substances of silver sulfadiazine gel by HPLC
Li Y, et al.
Chinese Journal of Hospital Pharmacy, 24(8), 474-474 (2004)
33 - Antimicrobial Drugs
Synthesis of Essential Drugs, 499-523 (2006)
Sulfadiazine
Pharmacopeia, US
United States Pharmacopeia/National Formulary, 4106-4106 (2018)
Development and validation of a stability-indicating HPLC method for the simultaneous determination of sulfadiazine sodium and trimethoprim in injectable solution formulation
Ghanem MM and Abu-Lafi SA
Scientia Pharmaceutica, 81(1), 167-182 (2013)
Sulfonamide antibiotics
Connor EE
Primary Care Update for OB/GYNS, 5(1), 32-35 (1998)
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